EDITOR’S NOTE: An earlier version of this article said Alberta, Ontario and Saskatchewan were pausing rollout of the AstraZeneca vaccine. Alberta is doing so, according to a senior source, while Ontario and Saskatchewan have been briefed on the updated guidance expected to come shortly.
The committee cited concerns over reports of blood clots as its reason for issuing the new guidance.
“As you’ve heard, rare cases of serious blood clots that have been associated with low platelts have been reported in Europe following use of AstraZeneca vaccine in those populations,” Dr. Shelley Deeks, vice-chair of the NACI said during a press conference Monday.
Deeks said NACI has “determined there is substantial uncertaintly” around the benefit of providing AstraZeneca to adults under 55 years of age given the potential risk .
Deeks said the NACI recommends those 55 and older can still receive the AstraZeneca vaccine.
So far, Deeks said the majority of the cases of the adverse effect– known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) — have been identified in women under the age of 55.
However, she said cases in men have also been reported.
Deeks added, though, that the majority of cases of VIPIT between four and 16 days after the patient received the vaccine.
Dr. Howard Njoo, the country’s deputy chief public health officer, said Health Canada will be pausing the use of the vaccine in those under 55 as a “precautionary measure,” while the agency conducts further “risk benefit assessment.”
Njoo said if you have received an AstraZeneca vaccine more than 20 days ago and have experienced no adverse effects there is “no cause for concern.”
He said anyone who received the shot less than 20 days ago should seek immediate medical attention if they experience any serious negative effects in the first four days.
Njoo said these side effects include shortness of breath, chest pain, leg swelling and persistent abdominal pain.
Njoo said while the cases of VIPIT are “rare,” Health Canada is taking the seriously.
“We need to take a pause and look and examine the evolving nature of what’s happening in Europe,” he said.
According to Health Canada, as of Thursday, a total of 500,000 doses of the AstraZeneca COVID-19 vaccine had been delivered across Canada.
Njoo said of those, around 307,000 doses have been administered in Canada.
Health Canada said in a statement Monday it has become aware that “additional cases” of blood clots and low blood platelets have occurred in people who have received the AstraZeneca vaccine.
“To date, no cases of these events have been reported in Canada,” the statement reads.
The agency said “in light of this evolving information,” it will be issuing additional “terms and conditions on the authorizations of the AstraZeneca and Verity Pharmaceuticals/Serum Institute of India vaccines.”
This includes a requirement that the manufacturers conduct a “detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context.”
Health Canada said this information will help with its “ongoing evaluation of these rare blood clotting events” and allow the agency to determine if specific groups are at a higher risk.
“Health Canada has been in discussions with AstraZeneca on this evolving issue.”
Provinces suspend use of AstraZeneca
The new recommendations from NACI come as public health officials in a number of provinces announced they would be suspending the use of the vaccine.
Manitoba and Quebec confirmed on Monday they are pausing rollouts to those under 55.
In a statement, Quebec’s health ministry said administration of the vaccine is “temporarily on hold pending expert assessments.”
British Columbia, Alberta and Saskatchewan have all decided to temporarily pause the use of the AstraZeneca vaccine in anyone under 55.
Ontario has also followed suit.
The province’s chief medical officer of Health Dr. David Williams told a press conference Monday afternoon that Ontario will follow the recommendations from NAC while it waits for more information.
Senior sources in Alberta, Ontario and Saskatchewan governments told Global News they were each informed of the change to NACI’s recommendations on Sunday night.
Prince Edward Island has also announced it will suspend the use of the vaccine in those under 55.
Last week, Health Canada added a blood clot warning to the vaccine’s label.
That came as federal health officials stressed that they want Canadians to be able to have confidence in the vaccine, which they said remains safe and effective.
“At this point in time, we, of course, believe that the benefits of the AstraZeneca vaccine continue to outweigh the risks,” said Dr. Supriya Sharma, chief medical advisor to Health Canada, last week.
The vaccine has been the subject of repeated questions over recent months.
More than a dozen European countries suspended use of the vaccine earlier in March over a blood clot scare.
The European Medicines Agency said on March 18 that it could not definitively rule out a link to blood clot incidents but that the benefits of vaccination outweighed the risks of getting COVID-19.
The disease caused by the coronavirus can also cause blood clots, along with a severe range of neurological and respiratory symptoms, as well as death.
The news of updated guidance for the vaccine comes as Canada is set to receive roughly 1.5 million doses of the AstraZeneca shot from the United States on Tuesday as part of a significant ramp up in vaccine deliveries from the three main manufacturers delivering vaccines so far.
Dr. Isaac Bogoch, an infectious diseases faculty member at the University of Toronto, said he thinks it is “very reasonable” to pause the rollout of the vaccine until we learn more.
He said right now it’s “not entirely clear” what the link is between the vaccine and reported blood clot cases.
“I think it’s fair to say that this chapter hasn’t been fully written,” he said.
Asked whether people who have received the AstraZeneca vaccine should be concerned, Bogoch said it’s good to be “aware of what’s happening.”
He added, though, that the AstraZeneca shot has proven to be a “very effective vaccine” for those over 55.
“There’s some excellent real-world data, for example, from the U.K. demonstrating that it reduces the risk of hospitalizations and deaths and infections and is safe,” he said. “So obviously there have been some communication failures from the company, there have been these events that you can’t ignore mostly in younger people.”
He said there needs to be open, honest and transparent communication from the company and researchers regarding the vaccine moving forward.
Bogoch said it needs to be delivered in a “very skilled way (so) that we can still have some confidence in the vaccine for people over the age of 55.”
“That’s going to be a challenge,” he said.
With files from Global’s David Akin and Mike Le Couteur.
With files from The Canadian Press.